Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”)
(Nasdaq: HRMY), a pharmaceutical company dedicated to developing
and commercializing innovative therapies for patients with rare
neurological diseases, today reported financial results and
business updates for the quarter ended June 30, 2023.
“This quarter represented the highest top line prescription
demand since our first full quarter of launch in 2020 and the
strongest quarter of new patient starts in our history,” said
Jeffrey M. Dayno, M.D., President and Chief Executive Officer at
Harmony. “This sustained momentum in our core business, driven by
robust underlying demand, reinforces our confidence in WAKIX being
a $1 billion plus opportunity in narcolepsy alone.”
“Our share repurchase program reflects our ongoing confidence in
the strength of our core business as well as our conviction in the
long-term growth potential for Harmony. Looking ahead, we made
significant progress in all of our current life cycle management
programs setting us up for a catalyst rich remainder of the
year.”
Second Quarter 2023 Financial Results
Net product revenues for the quarter ended June 30, 2023 were
$134.2 million, compared to $107.0 million for the same period in
2022. The 25% growth versus the same period in 2022 is primarily
attributed to strong commercial sales of WAKIX driven by continued
organic demand tapping into a large market opportunity
(approximately 80,000 patients diagnosed with narcolepsy in the
US), partially offset by specialty pharmacy buying patterns
resulting in lower trade inventory levels at the end of the
quarter. The average number of patients on WAKIX increased by
approximately 350 sequentially to approximately 5,450 patients for
the quarter ended June 30, 2023. We exited the quarter ended June
30, 2023, with approximately 5,600 patients on WAKIX.
GAAP net income for the quarter ended June 30, 2023, was $34.3
million, or $0.56 earnings per diluted share, compared to GAAP net
income of $23.5 million, or $0.39 earnings per diluted share, for
the same period in 2022. Non-GAAP adjusted net income was $45.9
million, or $0.76 earnings per diluted share, for the quarter ended
June 30, 2023, compared to Non-GAAP adjusted net income of $34.7
million, or $0.57 per diluted share, for the same period in
2022.
Reconciliations of applicable GAAP financial measures to
Non-GAAP financial measures are included at the end of this press
release.
Harmony’s operating expenses include the following:
- Research and Development expenses were $15.0 million in the
second quarter of 2023, as compared to $12.7 million for the same
quarter in 2022, representing a 18% increase;
- Sales and Marketing expenses were $24.5 million in the second
quarter of 2023, as compared to $20.2 million for the same quarter
in 2022, representing a 22% increase;
- General and Administrative expenses were $22.8 million in the
second quarter of 2023, as compared to $22.2 million for the same
quarter in 2022, representing a 3% increase; and
- Total Operating Expenses were $62.3 million in the second
quarter of 2023, as compared to $55.0 million for the same quarter
in 2022, representing a 13% increase.
As of June 30, 2023, Harmony had cash, cash equivalents and
investment securities of $429.6 million, compared to $345.7 million
as of December 31, 2022.
Company Updates
- Completed enrollment of Phase 3 registrational trial (INTUNE
Study) in adult patients with IH, nine months ahead of plan, and
on-track for topline data in the fourth quarter of 2023.
- Positive End-of-Phase 2 meeting with the U.S. Food and Drug
Administration (“FDA”). We plan to initiate a Phase 3 study in
patients with PWS in the fourth quarter of 2023.
- On-track for topline data from the Myotonic Dystrophy (“DM1”)
Phase 2 proof-of-concept signal detection trial in the fourth
quarter of 2023.
- Regarding a pediatric narcolepsy indication, we are working
with Bioprojet on the submission to FDA of a supplemental new drug
application (“sNDA”) for pediatric narcolepsy. We expect to
submit the sNDA in the fourth quarter of 2023.
- We are actively pursuing pediatric exclusivity for WAKIX and
have made progress with FDA in aligning on the requirements.
- Our Board of Directors authorized a $125 million share
repurchase program.
- We entered into a new $185 million term loan facility, further
strengthening the balance sheet and reducing annual interest
expense by approximately $6 million. Net proceeds from the new term
loan facility and cash on hand were used to repay existing
debt.
Conference Call Today at 8:30 a.m. ET We are
hosting our second quarter 2023 financial results conference call
and webcast today at 8:30 a.m. Eastern Time. The live and replayed
webcast of the call will be available on the investor relations
page of our website at https://ir.harmonybiosciences.com/. To
participate in the live call by phone, dial (800) 245-3047
(domestic) or +1 (203) 518-9765 (international), and reference
passcode HRMYQ223.
Non-GAAP Financial MeasuresIn
addition to our GAAP results, we present certain Non-GAAP metrics
including Non-GAAP adjusted net income and Non-GAAP adjusted net
income per share, which we believe provides important supplemental
information to management and investors regarding our performance.
These measurements are not a substitute for GAAP measurements, and
the manner in which we calculate Non-GAAP adjusted net income and
Non-GAAP adjusted net income per share may not be identical to the
manner in which other companies calculate adjusted net income and
adjusted net income per share. We use these Non-GAAP measurements
as an aid in monitoring our financial performance from
quarter-to-quarter and year-to-year and for benchmarking against
comparable companies.
Non-GAAP financial measures should not be
considered in isolation or as a substitute for comparable GAAP
measures; should be read in conjunction with our consolidated
financial statements prepared in accordance with GAAP; have no
standardized meaning prescribed by GAAP; and are not prepared under
any comprehensive set of accounting rules or principles. In
addition, from time to time in the future there may be other items
that we may exclude for purposes of our Non-GAAP financial
measures; and we may in the future cease to exclude items that we
have historically excluded for purposes of our Non-GAAP financial
measures.
About WAKIX® (pitolisant)
TabletsWAKIX, a first-in-class medication, is approved by
the U.S. Food and Drug Administration for the treatment of
excessive daytime sleepiness or cataplexy in adult patients with
narcolepsy and has been commercially available in the U.S. since Q4
2019. It was granted orphan drug designation for the treatment of
narcolepsy in 2010, and breakthrough therapy designation for the
treatment of cataplexy in 2018. WAKIX is a selective histamine 3
(H₃) receptor antagonist/inverse agonist. The mechanism of action
of WAKIX is unclear; however, its efficacy could be mediated
through its activity at H₃ receptors, thereby increasing the
synthesis and release of histamine, a wake promoting
neurotransmitter. WAKIX was designed and developed by Bioprojet
(France). Harmony has an exclusive license from Bioprojet to
develop, manufacture and commercialize pitolisant in the United
States.
Indications and UsageWAKIX is indicated for the
treatment of excessive daytime sleepiness or cataplexy in adult
patients with narcolepsy.
Important Safety Information
ContraindicationsWAKIX is contraindicated in
patients with known hypersensitivity to pitolisant or any component
of the formulation. Anaphylaxis has been reported. WAKIX is also
contraindicated in patients with severe hepatic impairment.
Warnings and PrecautionsWAKIX prolongs the QT
interval; avoid use of WAKIX in patients with known QT prolongation
or in combination with other drugs known to prolong the QT
interval. Avoid use in patients with a history of cardiac
arrhythmias, as well as other circumstances that may increase the
risk of the occurrence of torsade de pointes or sudden death,
including symptomatic bradycardia, hypokalemia or hypomagnesemia,
and the presence of congenital prolongation of the QT
interval.
The risk of QT prolongation may be greater in patients with
hepatic or renal impairment due to higher concentrations of
pitolisant; monitor these patients for increased QTc. Dosage
modification is recommended in patients with moderate hepatic
impairment and moderate or severe renal impairment (see full
prescribing information). WAKIX is not recommended in patients with
end-stage renal disease (ESRD).
Adverse ReactionsIn the placebo-controlled
clinical trials conducted in patients with narcolepsy with or
without cataplexy, the most common adverse reactions (≥5% and at
least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and
anxiety (5%). Other adverse reactions that occurred at ≥2% and more
frequently than in patients treated with placebo included headache,
upper respiratory tract infection, musculoskeletal pain, heart rate
increased, hallucinations, irritability, abdominal pain, sleep
disturbance, decreased appetite, cataplexy, dry mouth, and
rash.
Drug InteractionsConcomitant administration of
WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure
by 2.2-fold. Reduce the dose of WAKIX by half.
Concomitant use of WAKIX with strong CYP3A4 inducers decreases
exposure of pitolisant by 50%. Dosage adjustments may be required
(see full prescribing information).
H1 receptor antagonists that cross the blood-brain barrier may
reduce the effectiveness of WAKIX. Patients should avoid centrally
acting H1 receptor antagonists.
WAKIX is a borderline/weak inducer of CYP3A4. Therefore, reduced
effectiveness of sensitive CYP3A4 substrates may occur when used
concomitantly with WAKIX. The effectiveness of hormonal
contraceptives may be reduced when used with WAKIX and
effectiveness may be reduced for 21 days after discontinuation of
therapy.
Use in Specific PopulationsWAKIX may reduce the
effectiveness of hormonal contraceptives. Patients using hormonal
contraception should be advised to use an alternative non-hormonal
contraceptive method during treatment with WAKIX and for at least
21 days after discontinuing treatment.
There is a pregnancy exposure registry that monitors pregnancy
outcomes in women who are exposed to WAKIX during pregnancy.
Patients should be encouraged to enroll in the WAKIX pregnancy
registry if they become pregnant. To enroll or obtain information
from the registry, patients can call 1-800-833-7460. The safety and
effectiveness of WAKIX have not been established in patients less
than 18 years of age.
WAKIX is extensively metabolized by the liver. WAKIX is
contraindicated in patients with severe hepatic impairment. Dosage
adjustment is required in patients with moderate hepatic
impairment.
WAKIX is not recommended in patients with end-stage renal
disease. Dosage adjustment of WAKIX is recommended in patients with
moderate or severe renal impairment.
Dosage reduction is recommended in patients known to be poor
CYP2D6 metabolizers; these patients have higher concentrations of
WAKIX than normal CYP2D6 metabolizers.
Please see the Full Prescribing
Information for WAKIX for more information.
To report suspected adverse reactions, contact Harmony
Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
About NarcolepsyNarcolepsy is a rare, chronic,
debilitating neurological disease of sleep-wake state instability
that impacts approximately 165,000 Americans and is primarily
characterized by excessive daytime sleepiness (EDS) and cataplexy –
its two cardinal symptoms – along with other manifestations of REM
sleep dysregulation (hallucinations and sleep paralysis), which
intrude into wakefulness. EDS is the inability to stay awake and
alert during the day and is the symptom that is present in all
people living with narcolepsy. In most patients, narcolepsy is
caused by the loss of hypocretin/orexin, a neuropeptide in the
brain that supports sleep-wake state stability. This disease
affects men and women equally, with typical symptom onset in
adolescence or young adulthood; however, it can take up to a decade
to be properly diagnosed.
About Idiopathic HypersomniaIdiopathic
Hypersomnia (IH) is a rare and chronic neurological disease
that is characterized by excessive daytime sleepiness (EDS)
despite sufficient or even long sleep time. EDS in IH cannot be
alleviated by naps, longer sleep or more efficient sleep. People
living with IH experience significant EDS along with the symptoms
of sleep inertia (prolonged difficulty waking up from sleep) and
'brain fog' (impaired cognition, attention, and alertness). The
cause of IH is unknown, but it is likely due to alterations in
areas of the brain that stabilize states of sleep and
wakefulness. IH is one of the central disorders of hypersomnolence
and, like narcolepsy, is a debilitating sleep disorder that can
result in significant disruption in daily functioning.
About HBS-102HBS-102, an investigational
compound, is a melanin-concentrating hormone (MCH) receptor 1
(MCHR1) antagonist that targets MCH neurons in the brain. It has
the potential to be a first-in-class molecule with a novel
mechanism of action that could offer a new approach to the
treatment of a variety of rare neurological diseases.
About Harmony BiosciencesAt
Harmony Biosciences, we specialize in developing and delivering
treatments for rare neurological diseases that others often
overlook. We believe that where empathy and innovation meet, a
better life can begin for people living with neurological diseases.
Established by Paragon Biosciences, LLC, in 2017 and headquartered
in Plymouth Meeting, PA, our team of experts from a wide variety of
disciplines and experiences is driven by our shared conviction that
innovative science translates into therapeutic possibilities for
our patients, who are at the heart of everything we do. For more
information, please visit www.harmonybiosciences.com.
Forward Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including statements regarding our product WAKIX. These statements
are neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, the following: our commercialization efforts
and strategy for WAKIX; the rate and degree of market acceptance
and clinical utility of WAKIX, pitolisant in additional
indications, if approved, and any other product candidates we may
develop or acquire, if approved; our research and development
plans, including our development activities with Bioprojet, and
plans to explore the therapeutic potential of pitolisant in
additional indications; our ongoing and planned clinical trials;
the availability of favorable insurance coverage and reimbursement
for WAKIX; the timing of and our ability to obtain regulatory
approvals for pitolisant for other indications as well as any of
our product candidates, including those we are developing with
Bioprojet; our failure to achieve the potential benefits of the
2022 LCA with Bioprojet; our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing;
our ability to identify additional products or product candidates
with significant commercial potential that are consistent with our
commercial objectives; our commercialization, marketing and
manufacturing capabilities and strategy; significant competition in
our industry; our intellectual property position; loss or
retirement of key members of management; failure to successfully
execute our growth strategy, including any delays in our planned
future growth; our failure to maintain effective internal controls;
the impact of government laws and regulations; volatility and
fluctuations in the price of our common stock; the significant
costs and required management time as a result of operating as a
public company; the fact that the price of Harmony’s common stock
may be volatile and fluctuate substantially; statements related to
our intended share repurchases and repurchase timeframe and the
significant costs and required management time as a result of
operating as a public company. These and other important factors
discussed under the caption “Risk Factors” in our Annual Report on
Form 10-K filed with the Securities and Exchange Commission (the
“SEC”) on February 21, 2023, and our other filings with the SEC
could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any such forward-looking statements represent management’s
estimates as of the date of this press release. While we may elect
to update such forward-looking statements at some point in the
future, we disclaim any obligation to do so, even if subsequent
events cause our views to change.
HARMONY BIOSCIENCES HOLDINGS, INC. AND
SUBSIDIARY |
CONSOLIDATEDSTATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (In thousands, except share
and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net product revenues |
|
$ |
134,216 |
|
|
$ |
107,028 |
|
|
$ |
253,342 |
|
|
$ |
192,341 |
|
Cost of product sold |
|
|
25,008 |
|
|
|
18,921 |
|
|
|
45,788 |
|
|
|
33,637 |
|
Gross profit |
|
|
109,208 |
|
|
|
88,107 |
|
|
|
207,554 |
|
|
|
158,704 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
14,969 |
|
|
|
12,668 |
|
|
|
28,258 |
|
|
|
20,246 |
|
Sales and marketing |
|
|
24,528 |
|
|
|
20,160 |
|
|
|
47,100 |
|
|
|
37,743 |
|
General and administrative |
|
|
22,809 |
|
|
|
22,163 |
|
|
|
44,871 |
|
|
|
40,043 |
|
Total operating expenses |
|
|
62,306 |
|
|
|
54,991 |
|
|
|
120,229 |
|
|
|
98,032 |
|
Operating income |
|
|
46,902 |
|
|
|
33,116 |
|
|
|
87,325 |
|
|
|
60,672 |
|
Other (expense) income,
net |
|
|
(31 |
) |
|
|
42 |
|
|
|
(29 |
) |
|
|
40 |
|
Interest expense, net |
|
|
(2,776 |
) |
|
|
(3,927 |
) |
|
|
(5,421 |
) |
|
|
(8,096 |
) |
Income before income
taxes |
|
|
44,095 |
|
|
|
29,231 |
|
|
|
81,875 |
|
|
|
52,616 |
|
Income tax expense |
|
|
(9,795 |
) |
|
|
(5,700 |
) |
|
|
(18,090 |
) |
|
|
(7,600 |
) |
Net income |
|
$ |
34,300 |
|
|
$ |
23,531 |
|
|
$ |
63,785 |
|
|
$ |
45,016 |
|
Unrealized loss on
investments |
|
|
(491 |
) |
|
|
(29 |
) |
|
|
(371 |
) |
|
|
(29 |
) |
Comprehensive income |
|
$ |
33,809 |
|
|
$ |
23,502 |
|
|
$ |
63,414 |
|
|
$ |
44,987 |
|
EARNINGS PER SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.57 |
|
|
$ |
0.40 |
|
|
$ |
1.07 |
|
|
$ |
0.76 |
|
Diluted |
|
$ |
0.56 |
|
|
$ |
0.39 |
|
|
$ |
1.05 |
|
|
$ |
0.74 |
|
Weighted average number of shares of common stock - basic |
|
|
59,974,123 |
|
|
|
59,063,358 |
|
|
|
59,853,808 |
|
|
|
58,986,370 |
|
Weighted average number of shares of common stock - diluted |
|
|
60,743,953 |
|
|
|
60,922,672 |
|
|
|
60,997,410 |
|
|
|
60,759,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HARMONY BIOSCIENCES HOLDINGS,
INC.CONSOLIDATED BALANCE SHEETS
(In thousands except share and per share
data) |
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
317,415 |
|
|
$ |
243,784 |
|
Investments, short-term |
|
|
53,568 |
|
|
|
79,331 |
|
Trade receivables, net |
|
|
63,812 |
|
|
|
54,740 |
|
Inventory, net |
|
|
4,854 |
|
|
|
4,297 |
|
Prepaid expenses |
|
|
9,442 |
|
|
|
9,347 |
|
Other current assets |
|
|
6,550 |
|
|
|
8,786 |
|
Total current assets |
|
|
455,641 |
|
|
|
400,285 |
|
NONCURRENT ASSETS: |
|
|
|
|
|
|
Property and equipment, net |
|
|
572 |
|
|
|
573 |
|
Restricted cash |
|
|
250 |
|
|
|
750 |
|
Investments, long-term |
|
|
58,651 |
|
|
|
22,568 |
|
Intangible assets, net |
|
|
149,031 |
|
|
|
160,953 |
|
Deferred tax asset |
|
|
93,578 |
|
|
|
85,943 |
|
Other noncurrent assets |
|
|
2,460 |
|
|
|
2,798 |
|
Total noncurrent assets |
|
|
304,542 |
|
|
|
273,585 |
|
TOTAL ASSETS |
|
$ |
760,183 |
|
|
$ |
673,870 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Trade payables |
|
$ |
6,563 |
|
|
$ |
3,786 |
|
Accrued compensation |
|
|
7,972 |
|
|
|
11,532 |
|
Accrued expenses |
|
|
63,563 |
|
|
|
59,942 |
|
Current portion of long-term debt |
|
|
11,000 |
|
|
|
2,000 |
|
Other current liabilities |
|
|
3,947 |
|
|
|
1,624 |
|
Total current liabilities |
|
|
93,045 |
|
|
|
78,884 |
|
NONCURRENT LIABILITIES: |
|
|
|
|
|
|
Long-term debt, net |
|
|
180,487 |
|
|
|
189,647 |
|
Other noncurrent liabilities |
|
|
1,479 |
|
|
|
2,501 |
|
Total noncurrent liabilities |
|
|
181,966 |
|
|
|
192,148 |
|
TOTAL LIABILITIES |
|
|
275,011 |
|
|
|
271,032 |
|
COMMITMENTS AND CONTINGENCIES (Note 12) |
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
Common stock—$0.00001 par value; 500,000,000 shares authorized at
June 30, 2023 and December 31, 2022,
respectively; 59,999,658 shares and 59,615,731 issued and
outstanding at June 30, 2023 and
December 31, 2022, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid in capital |
|
|
694,038 |
|
|
|
675,118 |
|
Accumulated other comprehensive (loss) income |
|
|
(522 |
) |
|
|
(151 |
) |
Accumulated deficit |
|
|
(208,345 |
) |
|
|
(272,130 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
|
485,172 |
|
|
|
402,838 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
760,183 |
|
|
$ |
673,870 |
|
HARMONY BIOSCIENCES HOLDINGS,
INC.RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL
RESULTS(In thousands except share and per share
data) |
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
GAAP net income |
|
$ |
34,300 |
|
|
$ |
23,531 |
|
|
$ |
63,785 |
|
|
$ |
45,016 |
|
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash interest expense (1) |
|
|
424 |
|
|
|
411 |
|
|
|
840 |
|
|
|
823 |
|
Depreciation |
|
|
103 |
|
|
|
94 |
|
|
|
206 |
|
|
|
211 |
|
Amortization (2) |
|
|
5,961 |
|
|
|
5,961 |
|
|
|
11,922 |
|
|
|
11,043 |
|
Stock-based compensation expense |
|
|
7,793 |
|
|
|
7,371 |
|
|
|
14,354 |
|
|
|
12,267 |
|
Income tax effect related to non-GAAP adjustments (3) |
|
|
(2,712 |
) |
|
|
(2,662 |
) |
|
|
(5,112 |
) |
|
|
(3,516 |
) |
Non-GAAP adjusted net
income |
|
$ |
45,869 |
|
|
$ |
34,706 |
|
|
$ |
85,995 |
|
|
$ |
65,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP reported net
income per diluted share |
|
$ |
0.56 |
|
|
$ |
0.39 |
|
|
|
1.05 |
|
|
$ |
0.74 |
|
Non-GAAP adjusted net income
per diluted share |
|
$ |
0.76 |
|
|
$ |
0.57 |
|
|
|
1.41 |
|
|
$ |
1.08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock used in non-GAAP diluted per share |
|
|
60,743,953 |
|
|
|
60,922,672 |
|
|
|
60,997,410 |
|
|
|
60,759,026 |
|
(1) Includes amortization of deferred finance charges(2)
Includes amortization of intangible asset related to WAKIX (3)
Calculated using the reported effective tax rate for the periods
presented less impact of discrete items
Harmony Biosciences Investor Contact:Luis
Sanay, CFA445-235-8386lsanay@harmonybiosciences.com
Harmony Biosciences Media Contact:Cate
McCanless202-641-6086cmccanless@harmonybiosciences.com
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